Drugs

Compliance

Below is a sortable listing of Compliance Guidances

CategoryTitleTypeDate
Compliance Review of FDA's Implementation of the Drug Export Amendments of 1986 (PDF - 2MB) Final Guidance 11/01/89
Compliance Good Laboratory Practice Regulations Questions and Answers (PDF - 2.2MB) Final Guidance 03/02/98
Compliance Nuclear Pharmacy Guideline Criteria for Determining When to Register as a Drug Establishment (PDF - 3.5MB) Final Guidance 03/02/98
Compliance Street Drug Alternatives (PDF - 11KB) Final Guidance 03/01/00
Compliance Prescription Drug Marketing Act — Donation of Prescription Drug Samples to Free Clinics (PDF - 38KB) Final Guidance 03/01/06
Compliance Prescription Drug Marketing Act (PDMA) Requirements- Questions and Answers (PDF - 112KB) Final Guidance 11/13/06
Compliance Guidance for Industry: Computerized Systems Used in Clinical Investigations (PDF - 53KB) Final Guidance 05/10/07
Guidance for Industry: Bar Code Label Requirements (PDF - 72KB)
Compliance Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products (PDF - 595KB) Final Guidance 05/04/11
Compliance Marketed Unapproved Drugs -- Compliance Policy Guide (PDF - 164KB) Final Guidance 09/19/11
Compliance; Pharmaceutical Quality/Manufacturing Standards (CGMP) Contract Manufacturing Arrangements for Drugs: Quality Agreements (PDF - 123KB) Final Guidance 11/22/16
Compliance; Over-the-Counter Recommended Warning for Over-the-Counter Acetaminophen-Containing Drug Products and Labeling Statements Regarding Serious Skin Reactions (PDF - 89KB) Final Guidance 01/11/17
Compliance Recommended Statement for Over-the-Counter Aspirin-Containing Drug Products Labeled With Cardiovascular Related Imagery Guidance for Industry (PDF - 58KB) Draft Guidance 01/11/17

Page Last Updated: 01/11/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English